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Molecular Analysis for Therapy Choice (MATCH)
MATCH Treatment Subprotocol E: AZD9291 in Patients with Tumors Having EGFR T790M
Mutations (Except Non-Small Cell Lung Cancer) or Rare Activating Mutations of EGFR
Treatment: AZD9291 80mg orally once daily continuously. A cycle is defined as 28 days. Drug Provided.
Eligibility Criteria
1. Patient must fulfill all eligibility criteria outlined in Section 3.1 of MATCH Master Protocol (excluding
section 3.1.16) at the time of registration to treatment step (Step 1, 2, 5, 7).
2. Patients must have either:
a. Any malignancy other than lung adenocarcinoma and have EGFR T790M identified in their tumor,
with or without an activating mutation OR
b. Any malignancy harboring any of the following mutations: EGFR G719A, G719C, G719D, G719S
EGFR L861Q, S786I or an EGFR exon 19 in frame insertion mutation. See Appendix IV for a list of
the EGFR mutations and corresponding Levels of Evidence.
3. Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must
have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g.
complete left bundle branch block, third degree heart block.
4. Patients must have an ECHO or a nuclear study (MUGA or First Pass) within 4 weeks prior to
registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional
lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be >50% for the patient
to be eligible.
5. Patients must not have known hypersensitivity to AZD9291 or compounds of similar chemical or
biologic composition.
6. Patient must not have received AZD9291, WZ4002, CO-1686, HM61713, EGF816 or ASP8273
previously.
7. Patients known to harbor germline EGFR T790M mutations are excluded from the study. Prospective
testing for germline mutations is not required.
Study Parameters
EAY131-E [pv3/3/16]
Version 2
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